This week Rimsys became an associate member of MedTech Europe, the European trade association representing the medtech industry, alongside some of the world’s largest medical technology companies. As a member of the organization, we’ll have visibility into regulatory changes across the region as they’re being formed, and the opportunity to shape how those regulations are implemented. This access will help us to ensure that the digitization and automation of regulatory processes remains in reach for all medtech companies, and that our software will be best positioned to help them.
What is MedTech Europe?
MedTech Europe is a trade association focused on making innovative medical technology available to more people, and making healthcare systems more sustainable. Members of the organization include medical technology companies—device and in vitro diagnostic manufacturers, industry service and technology providers, and country-level associations within the European region.
The organization serves as a trusted resource of medical technology information for the public, providing data and highlighting the value of new technologies, and for policy-makers and other key stakeholders. It publishes industry research and statistics, contributes to health-related policy and legislation, and works to expand patient and provider access to new, lifesaving technologies.
Why did we join?
At Rimsys, we’re passionate about the medical technology industry, and focused on providing technology solutions to help medtech companies strengthen regulatory compliance, and bring new products to market more quickly. The European region is a focal point for medical technology regulation, and the MDR/IVDR regulations that began to take effect this year will inform the approaches of health authorities around the world.
Regulatory digitization and automation happens both at the manufacturer level and the health authority level. MDR/IVDR brings unique device identification (UDI) requirements, and a centralized technology system for product and post market surveillance information (EUDAMED) to the market. Both of these elements are digital by nature, and can serve as end-points of automated processes run within the Rimsys Platform.
Earlier this year, we introduced a new approach to UDI, one that ties together market requirements, product information, registrations, and selling status in an integrated regulatory lifecycle. Rather than managing UDI data separately from other regulatory information and activities, companies can auto-populate compliant UDI information directly, and will soon be able to submit that information electronically to the EUDAMED database. As a MedTech Europe member, we can participate in working groups around these systems, and ensure that we have the insights and access that we need to develop and deliver features like this for our customers.
How does this benefit our customers?
For Rimsys customers, this is all about maximizing the value they can get from our holistic Regulatory Information Management (RIM) platform. Our platform is designed to support a wide range of regulatory processes, and many of these processes are shaped by the regulations themselves. As members of MedTech Europe, we’ll be involved in policy discussions as they happen, and can ensure that the updates we make and features that we add are in alignment with the latest regulations. Understanding how regional policy is evolving also allows us to share that intelligence in-product—alerting customers to relevant changes, and updating market entrance requirements.
The second key benefit is access. The automation of regulatory processes is most effective when it can be done end to end. This therefore includes interactions with health authorities. Government agencies, including the European Commission, are establishing digital channels for product registration, UDI, and clinical and post market surveillance data. Our goal at Rimsys is to provide as many direct integrations with these systems as possible. As MedTech Europe members, we’ll be part of the groups that advise policy-makers, and help to develop these systems. As a result, we can help to ensure that our integrations are as functional and effective as possible.
Learn more about automation and digitization for regulatory affairs
Whether you distribute medical products in the European Union or in other markets, there can be significant benefits associated with digitizing and automating regulatory processes including better information access, more cross-company collaboration, less manual administrative work, and faster time to market for new products. To learn some more, see the Top 6 Benefits of a RIM system, or contact us to request a custom demo.